Objectives To evaluate the efficacy of primary tumor bulk reduction and the safety of concurrent chemoradiotherapy in combination with H101, a type of oncolytic virus, for the treatment of locally advanced cervical cancer.

Methods Patients diagnosed with stage IIB or III cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO 2009), with tumor length ≥6 cm, were enrolled at Zhejiang Cancer Hospital from July 2015 to April 2017. All patients received concurrent chemoradiotherapy in combination with intratumoral H101 injection before and during external beam radiotherapy. Outcomes included progression free survival, overall survival, tumor regression after external beam radiotherapy, and side effects.

Results A total of 23 patients were included in the safety analysis and, of these, 20 were included in the efficacy analysis. Median follow-up time was 38 (range 10–58) months. The 3 year local, regional, and overall progression free survival rates for the 20 patients were 95%, 95%, and 65%, respectively, and the 3 year overall survival rate was 74.3%. Median tumor length was reduced from 6.6 cm (range 6–7.3) before treatment to 4.1 cm (range 2.2–5.5) after external beam radiotherapy. Median tumor volume was reduced from 88.4 cm³ (range 41.2–126) before treatment to 20.8 cm³ (range 11.1–47.4) after external beam radiotherapy. Median percentage reduction of tumor length and volume were 37.7% and 75.1%, respectively. The major adverse event related to H101 was fever (91.3%).

Conclusion H101 injection may enhance primary tumor regression for locally advanced cervical cancer, with an acceptable safety profile. This treatment regimen should undergo further prospective randomized controlled studies.

ChiCTR-OPC-15006142.